Wednesday, July 13, 2011

FDA warns against surgical mesh to repair pelvic problems

Women who have vaginal surgery to fix a common gynecologic problem, called pelvic organ prolapse, may wind up with more problems than benefits if mesh is used to repair it, according to a safety communication issued today by the Food and Drug Administration that warns patients and surgeons to consider other options.

The agency said it plans to convene an advisory committee of experts in the fall to determine whether to ban the mesh -- manufactured by Natick-based Boston Scientific Corp. and several other companies -- for this procedure.

More than 100,000 women a year with pelvic organ prolapse are treated with plastic mesh, but in most cases, the agency said, the condition “can be treated successfully without mesh.”

In 2008, the FDA announced that “rare” problems could be associated with transvaginal placement of the mesh, which is used along with surgical stitches to support sagging pelvic organs like the bladder, uterus, and bowel after they’ve been lifted back out of the vagina where they descended. Mesh-related problems include painful sexual intercourse, infections, urinary problems, overall discomfort, and bleeding usually from the mesh eroding through the stitched tissue or from skin contracting tightly around it.

From 2008 to 2010, the FDA received 1,503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. It also received three reports of deaths that were related to the mesh placement procedure.

Recent studies indicate that about 10 percent of women who have the mesh placed transvaginally experience mesh erosion within 12 months of surgery and that more than half of them require additional surgeries to remove the mesh. Less commonly, the mesh becomes so intertwined with scar tissue that it can’t be removed surgically.

“For women with unresolved pain from mesh that can’t be removed, their options can be limited,” said FDA medical officer Dr. Jill Brown.

What’s more, the FDA found that the mesh doesn’t make the surgery any more effective. “The evidence we reviewed calls into question the clinical benefit of mesh, and it certainly shouldn’t be used routinely for all transvaginal prolapsed repairs,” said Dr. William Maisel the FDA’s deputy director of the Center for Devices and Radiological Health.

In 2010, 75,000 women had vaginal surgery with mesh to repair POP. That surgery was performed three times as often as abdominal surgical mesh repair, according to the FDA, since it doesn’t require a painful incision through the skin and offers a less painful recuperation for women. Abdominal mesh repair, however, doesn’t pose the same risk of problems.

“With abdominal surgery, we don’t have to make an incision through the vaginal wall to place the mesh, so rates of complications really plummet; it makes a huge difference,” said Dr. May Wakamatsu, head of the urogynecology division at Massachusetts General Hospital. She and the two other surgeons at the hospital who repair POP have largely switched to abdominal entry using a laparascope or robotic device that involves making small incisions in the skin.

“We find ourselves doing the vaginal surgery less and less,” Wakamatsu said, “only on complicated patients with previous abdominal surgeries, endometriosis, or congenital defects.” She said in her experience the mesh, when inserted through the abdomen, has been helpful at providing support for organs after the repair. She also uses smaller pieces fashioned into slings to surgically fix problems associated with urinary incontinence.

The FDA cited studies showing that abdominal mesh repair for POP led to vaginal erosion in 4 percent of women within 23 months of surgery

Even with today’s FDA announcement, surgeons can still opt to use the mesh for vaginal POP repair, but many may opt not to use it after today’s announcement. The FDA urged patients with the condition to ask their surgeon about all treatment options, including those without mesh, before having the operation.

What impact this will have on the already falling fortunes of Boston Scientific -- especially if more patients who’ve had problems decide to sue, as some already have -- remains an open question.

Boston Scientific spokesman Erik Kopp this morning said the company is looking into the matter and had no immediate comment.

The company’s shares were trading down 3 cents, or 0.4 percent, at $7.25 at 11:45 a.m. One stock analyst, who spoke on the condition of anonymity because he had not yet read the FDA safety communication, said he doubted it would hurt Boston Scientific’s stock because the mesh was a relatively small part of the company’s product line and the safety alert also applied to other companies.

The medical device maker has suffered a string of setbacks in recent years involving two of its best-selling cardiac products: tiny mesh tubes known as stents that are implanted to keep cleared arteries open, and implantable devices called defibrillators that apply electric shocks to restore heart rhythm.

Last year, Boston Scientific struck the largest legal settlement in its 30-year history, agreeing to pay more than $1.7 billion to rival Johnson & Johnson to resolve three patent disputes in which the companies had accused each other of intellectual property theft in developing stents. That deal followed a 2009 settlement in which Boston Scientific agreed to pay $716 million to resolve 14 other patent suits brought by Johnson & Johnson.

In a lawsuit filed against Boston Scientific in January, the Justice Department alleged that the company’s Guidant subsidiary knowingly sold defective defibrillators and hid potentially dangerous defects from patients. That complaint was lodged two weeks after a Minnesota judge accepted a Guidant guilty plea on charges of concealing defibrillator problems. Boston Scientific, which acquired Guidant for $28.4 billion in 2006, agreed to pay $240 million the following year to settle more than 8,000 private suits charging that Guidant hid defibrillator problems.

The company’s shares traded over $40 in 2004 before the setbacks. Boston Scientific chief executive, J. Raymond Elliott, hired in 2009 to revive the company’s fortunes, said in May that he plans to resign at the end of the year. Elliott was paid $4.9 million last year after receiving a 2009 compensation package, including stock and options, that was potentially worth $33.4 million.

12 comments:

There are a number of case studies comparing the benefits of pelvic mesh implants compared to more traditional methods for POP surgery and the results for long term are unclear. The mesh kits, back in 2002 when they were first approved, lacked the long term data to prove it's effectiveness and the FDA should have ordered clinical trials and premarket approval, steps that were skipped in the case of POP mesh kits.

Exactly! Not only that, I also think that the FDA are too slow and inaccurate with their announcements. Check this out! According to http://www.rotlaw.com/transvaginal-placement-of-surgical-mesh/ :The FDA first released a public health notification cautioning doctors about the risks associated with surgical mesh in 2008. Issued in response to surgical mesh manufacturers’ receipt of “over 1,000” adverse-event reports associated with attempts to remedy POP and Stress Urinary Incontinence (SUI) by placing surgical mesh transvaginally (that is, through a woman’s vagina as opposed to through her abdomen), the notification stated that such complications were serious, but “rare.”

Between the 2008 release of that Health Safety Communication and 2010, serious complaints about complications related to the use of surgical mesh to treat POP increased five-fold, according to the FDA. Moreover, the agency’s systematic review of the relevant scientific literature published from 1996 to 2011 “showed that transvaginal POP repair with mesh does not improve symptomatic results or quality of life over traditional non-mesh repair.”

Accordingly, the FDA issued a safety communication on July 13, 2011, announcing that “serious complications associated with surgical mesh for transvaginal repair of POP are not rare.”